CK Isoenzyme Electrophoresis Control-I.D
FDA 510(k) K800604 · Beckman Instruments, Inc.
510(k) numberK800604
Submission
- Device name
- CK Isoenzyme Electrophoresis Control-I.D
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- March 17, 1980
- Decision date
- April 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJT – Enzyme Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was CK Isoenzyme Electrophoresis Control-I.D cleared by the FDA?
CK Isoenzyme Electrophoresis Control-I.D (K800604) received a 510(k) decision of Substantially Equivalent on April 10, 1980, 24 days after the submission was received.
What is the product code of K800604?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.